BRAVO: Fewer Adverse Events with Bivalirudin vs. Heparin After Aortic Valvuloplasty

SAN FRANCISCO, CALIF.—In a study of patients who received either bivalirudin or heparin for non-emergent, balloon aortic valvuloplasty, bivalirudin was associated with less bleeding, according to a presentation at TCT 2011.

For the BRAVO study, George D. Dangas, MD, PhD, of the Mount Sinai Medical Center, New York, and colleagues conducted a retrospective analysis of 428 patients from two high-volume centers who underwent balloon aortic valvuloplasty. Bivalirudin (0.375-0.75 mg/kg bolus IV, followed by IV infusion at 1.75 mg/kg/hr) was given to 223 patients, while unfractionated heparin (50 IU/kg bolus IV with supplemental boluses to maintain activated clotting time between 200-250 seconds) was given to 205 subjects. Patients undergoing shorter procedures were given a bolus at the operators’ discretion and a reduced dose was used in patients at high risk of bleeding. All adverse events were adjudicated by an independent clinical events committee.

The primary endpoint was in-hospital major bleeding defined as BARC type greater than or equal to 3, while secondary endpoints included bleeding according to VARC, TIMI and GUSTO definitions, as well as MACE, NACE and other complications.

Less major bleeding, adverse events

Overall, fewer patients in the bivalirudin group than in the heparin group experienced in-hospital major bleeding on various bleeding scores (see Figure 1).

The bivalirudin group also experienced fewer in-hospital major adverse events compared with heparin patients (see Figure 2).

BRAVO Figure 1

BRAVO Figure 2In multivariate analysis, bivalirudin was an independent predictor of less bleeding (OR .37 [0.16-0.82]; P=.02) and prior balloon aortic valvuloplasty was an independent predictor of more bleeding (OR 3.09 [1.08-8.87]; P=.04).

“Bleeding reduction with bivalirudin was accentuated in patients who had attempted preclosure with an arteriotomy closure device,” Dangas added. Major bleeding in bivalirudin patients with preclosure was 2.5% vs. 10.8% with no preclosure (P=.02). In the heparin group, major bleeding occurred in 14.9% with no preclosure vs. 12.0% with preclosure (P=.54).

Dangas noted that patients in the bivalirudin group were slightly older than those in the heparin group (84.3 years vs. 82.4, P=.03) and tended to have more hyperlipidemia (76.2% vs. 67.3, P=.04). In addition, fewer patients in the bivalirudin group had one or more previous balloon aortic valvuloplasties compared with the heparin group (3.8% vs. 9.3% P=.03).

Disclosures
  • Dr. Dangas reports receiving research grants and consulting fees from numerous companies.

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